Description
Regulatory Affairs Officer - TipperaryMy client is a company dedicated to the successful registration and launch of generic pharmaceutical products throughout the EU, South Africa, Australia, New Zealand and MENA territories. Due to their continued expansion they are currently looking for a bright candidate to join their regulatory team which is based in Tipperary.
The ideal candidate will have a sound knowledge of European submission procedures and electronic applications (both NeeS and eCTD).
Responsibilities/Tasks:
- Management of a specific portfolio of products
- Submission of new MAAs (abridged) in the EU via national, MRP, DCP routes
- Post-licensing activities (variations, renewals, PSURs, etc.)
- Providing regulatory support for out-licensing activities in EU and non-EU territories
- Planning and tracking of regulatory procedures through to completion in a timely manner
- Liaising with other departments and external parties to generate supporting data for submissions
- Reviewing documentation to ensure compliance with MA details and relevant guidelines and Directives
Key Competences:
- Knowledge and application of registration procedures in Europe (national/MRP/DCP)
- Knowledge and application of the content and format of registration files (CTD)
- Knowledge and application of requirements for product information (QRD template, user testing, Braille, etc.)
- Understanding of pharmacovigilance and the role of the QPPV
- Knowledge and application of change control to regulatory procedures
- Knowledge of EU regulatory framework
- Strong communication skills is essential
If you are interested in this position please contact me John Lennon on for more information and immediate consideration. They will ideally be looking for the successful candidate to start in February 2016.